Immuno-virological Evaluation of People Living with HIV
Official title: Immuno-virological Evaluation of Persons Living With HIV (PLWH) Who Initiated Anti-retroviral Treatment (ART) During Acute HIV Infection and of PLWH on Long Term ART
Run by University Hospital, Ghent · NCT05973825 · Data updated 2026-11-12
This study will test immune and viral factors in two groups of people with HIV who have been on stable ART for different lengths of time.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Status | Recruiting |
| Started | February 13, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT05973825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–79 with HIV-1 infection and long-term, stable viral suppression on ART, meeting the study’s leukapheresis and sample storage requirements.
✕Probably not a fit
Participants who do not meet the eligibility criteria or who do not benefit from the specific in vitro latency-targeting interventions may not experience direct clinical benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective study enrolls adults with HIV who have had suppressed viral loads on ART. It uses leukapheresis and blood samples to analyze latent viral reservoirs, including proviral genomes, transcriptomes, epigenomes, and T cell receptors, in two cohorts: short-term ART (2–10 years since ART start) and long-term ART (>20 years). Researchers will test latency-reversal strategies in vitro and profile infected cells to understand latency and potential cure approaches. Data from participants and samples will be shared among collaborating centers to advance HIV cure research.
Why it matters
Potential benefit: If successful, the study could improve understanding of HIV latency and help develop strategies toward an HIV cure.
How similar studies have gone: Prior studies have explored HIV latency and reservoir biology; this study extends those efforts with two well-defined cohorts and detailed multi-omics analyses.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort 1: short-term ART cohort * Documented HIV-1 infection * Able and willing to provide written informed consent * Age = or \>18 years and \< 80 years * ART started during a documented recent HIV-1 infection (acute HIV infection, defined as: * Clinical symptoms of acute seroconversion and incomplete Western Blot, or * Negative screening test within the past 6 months and incomplete Western Blot, or * Risk contact within the \<3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot. * Being on ART since minimum 2 years and maximum 10 years * Participants should have had a routine plasma viral load measurement at least once a year. * Viral load \< 40 or \<50 copies/ml determined by the assay (used in the local centers) for at least 3 years (one blip \< 200 copies/ml is allowed) * Ability and willingness to have blood samples collected and stored for 20 years and used for various research purposes. * Patients with HIV-1 subtype B are preferred for inclusion (as most of the complex assays are subtype B specific). However, if the investigators do not reach our target of 10 participants, patients infected with other subtypes will be allowed to enter the study. (Primers will subsequently be adapted to the patient-specific proviral sequences). Cohort 2: long-term ART cohort * Documented HIV-1 infection * Able and willing to provide written informed consent * Age = or \>18 years and \< 80 years * Being on ART since at least 20 years * ART should not have been started during a documented recent HIV-1 infection (acute HIV infection), defined as: * Clinical symptoms of acute seroconversion and incomplete Western Blot or * Negative screening test within the past 6 months and incomplete Western Blot or * Risk contact within \<3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot. * Patients should have had a routine plasma viral load measurement at least once a year. * Routine plasma viral load \< 40 or \<50 copies/ml determined by the assay used in the local centres for at least 20 years (one blip \< 200 copies/ml is allowed if it occurred \>10 years ago) * Ability and willingness to have blood samples collected and stored for 20 years and used for various research purposes. * Participants with HIV-1 subtype B are preferred for inclusion (as most of the complex assays are subtype B specific). However, if the investigators do not reach our target of 10 participants, patients infected with other subtypes will be allowed to enter the study. (Primers will subsequently be adapted to the patient-specific proviral sequences). Exclusion Criteria: * Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the Centers for Disease Control and Prevention (CDC) clinical classification), consisting of chronic HIV-1 infection. * Evidence of active Hepatitis B-virus (HBV) infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (= HBV antigen or viral load negative and positive HBV surface antibody). * Evidence of active HCV infection (HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry). * Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease. * Current cancer. * History of HIV-related thrombocytopenia. * Pregnancy or breastfeeding. * Any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant. * Abnormal results of standard of care laboratory tests: 1. Confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men 2. Confirmed platelet count \<100 000/µl \* 3. Confirmed neutrophil count \<1000/μl 4. Confirmed Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>10x upper limit of normal (ULN) * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
Where it's running
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UZ Gent
Ghent, Oost-Vlaanderen, Belgium Recruiting
Study contacts
- Principal investigator: Linos vandekerckhove — UZ Gent
- Study coordinator: Linos Vandekerckhove
- Email: linos.vandekerckhove@ugent.be
- Phone: +3293323398
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.